Cleared Traditional

K221653 - InfaTherm Disposable Infant Warming Mattress (FDA 510(k) Clearance)

Class I Physical Medicine device.

K221653 · International Biomedical · Physical Medicine device
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Oct 2022
Decision
121d
Days
Class 1
Risk

K221653 is an FDA 510(k) clearance for the InfaTherm Disposable Infant Warming Mattress. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on October 6, 2022 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5710 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all International Biomedical devices

Submission Details

510(k) Number K221653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2022
Decision Date October 06, 2022
Days to Decision 121 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 115d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IMD Pack, Hot Or Cold, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5710
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.